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Omitting GnRH-antagonist Dose on the Day of Ovulation Trigger

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044756
Recruitment Status : Unknown
Verified February 2017 by Osama Saber Thabet Abdalmageed, Assiut University.
Recruitment status was:  Recruiting
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Osama Saber Thabet Abdalmageed, Assiut University

Brief Summary:
Omitting the GnRH antagonist on the day of the trigger can be cost effective and more convenient to the women. We will study the impact of omitting the antagonist dose in a prospective randomized trial

Condition or disease Intervention/treatment Phase
Pituitary Downregulation Drug: Omit Citrotide 0.25 dose on the day of triggering of ovulation Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled study
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Omitting GnR-antagonist on Ovulation Trigger Day in the Fresh Autologous IVF/ICSI Cycles
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : August 30, 2017
Estimated Study Completion Date : December 30, 2017

Arm Intervention/treatment
Experimental: -ve arm
The women who do not receive the GnRH antagonist dose on the day of triggering of ovulation (omitted GnRH antagonist arm)
Drug: Omit Citrotide 0.25 dose on the day of triggering of ovulation
Omit Citrotide 0.25 dose on the day of triggering of ovulation

No Intervention: +ve arm
The women who receive the routine dose of GnRH antagonist on the day of triggering of ovulation (the usual protocol)



Primary Outcome Measures :
  1. Number of retrieved oocytes [ Time Frame: One Month ]
    total number and maturation of the retrieved oocytes



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All antagonist cycle ivf who agree to participate

Exclusion Criteria:

  • expected poor responders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044756


Locations
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Egypt
Osama Abdalmageed Recruiting
Assiut, Non-US/Non-Canadian, Egypt, 71111
Contact: Osama Abdalmageed    1007972027    drosamast1981@gmail.com   
Osama Abdalmageed Recruiting
Assiut, Non-US/Non-Canadian, Egypt, 71111
Contact: Osama Abdalmageed       drosamast1981@gmail.com   
Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: Osama Saber Thabet Abdalmageed, Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity, Assiut University
ClinicalTrials.gov Identifier: NCT03044756    
Other Study ID Numbers: Omit
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The regulations in Assiut University do not allow protected patient data sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Osama Saber Thabet Abdalmageed, Assiut University:
GnRH antagonist
Pituitary downregulation
IVF
ICSI
Additional relevant MeSH terms:
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Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases